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CAPSTONE CONTROL™ Spinal System 4011422Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 4011422 12 DEG 14X22 · Class 2 · Implant

All models of CAPSTONE CONTROL Spinal System (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169108981), received between Sep 11, 2018 and Sep 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Loose or Intermittent Connection1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY DUE TO SPINAL CANAL STENOSIS. INTRA-OP, WHEN THE CAGE WAS HAMMERED, IT WAS FOUND THAT THE LOCK WAS LOOSE. IT WAS ATTEMPTED TO BE TIGHTENED BUT IT SEEMED THAT THE THREAD WAS BROKEN AND IT COULD NOT BE LOCKED. NO PATIENT'S SYMPTOMS AND COMPLICATION WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7863626 ↗

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Sources and updates

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